DEFENSE HEALTH AGENCY 7700 ARLINGTON BOULEVARD, SUITE 5101 FALLS CHURCH, VIRGINIA 22042-5101 MEMORANDUM FOR DEPUTY CHIEF, READINESS AND HEALTH, BUREAU OF MEDICINE AND SURGERY DEPUTY CHIEF OF STAFF G-3/5/7, OFFICE OF THE SURGEON GENERAL DIRECTOR, MEDICAL OPERATIONS AND RESEARCH, OFFICE OF THE SURGEON GENERAL DIRECTOR, NATIONAL CAPITAL REGION MEDICAL
DIRECTORATE SUBJECT: Use of Regenerative Medicine Advanced Therapy (RMAT) Products Not Approved by the Food and Drug Administration (FDA).
Regenerative Medicine Advanced Therapy (RMAT) products not approved by the FDA have the potential to expose patients to unnecessary risk. One such product is injectable micronized dehydrated human amnion/chorion membrane (dHACM) used to treat conditions such as plantar fasciitis, tendonitis or osteoarthritis. Any of these products not approved by the FDA are considered investigational, at present. Therefore, effective immediately, all MHS facilities will stop using injectable RMAT products not approved by the FDA, including dHACM. Once the FDA has approved an RMAT product, further review will occur. The Veteran’s Administration has taken a similar action.
PAUL R. CORDTS, MD Deputy Assistant Director – Medical Affairs Defense Health Agency
At the same time I was made aware of the above Defense Department Memorandum, a patient called my attention to a brochure she had received in the mail on the same day recruiting “victims” to one of several offices in metropolitan Chicago treating patients with the very product that the Defense Health Agency classified as unapproved by the FDA and therefore prohibited for safe use. A day later. I received an e-mail from a health care provider out of state, a non-MD asking me about use of “stem cells and amniotic fluid in my office.”
Are these alleged members of the health care community charlatans, uninformed, or just plain dumb and dumber? “Beware, take care, of the Green-eyed dragon with 13 tails, he’ll feed, with greed”. There is only one FDA approved source of stem cells for arthritis available in the United States and I am pleased to have been designated a Clinical Investigator in the PSC Trial. You may read about it on my website at www.sheinkopmd.com or at www.personalizedstemcells.com . The other potential biologic alternatives that, to the best of my knowledge are approved at this time, involves using your bone marrow as a regenerative option for delivering Adult Mesenchymal Stem Cells, or Platelet Rich Plasma obtained from your circulating blood as resource for Growth Factors.
To learn more or to schedule a consultation, call (312) 475-1893
Tags: clinical trials, FDA approved stem cell research, regenerative medicine, stem cell research